RHAPSIDO
- Product NDC
- 0078-1483
- 11-digit product format
- 000781483
- Labeler code
- 0078
- Product ID
- 0078-1483_9e44a793-9940-4ae3-9fe6-0f901afa37e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- remibrutinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA218436
- Marketing category
- NDA
- Marketing start
- 2025-09-30
- Substance
- REMIBRUTINIB
- Active strength
- 25 mg/1
- Pharmacologic classes
- Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RHAPSIDO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REMIBRUTINIB | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I7MVZ8HDNU |
| Rxcui | 2724392, 2724398 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-1483-20 | RHAPSIDO | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 0078-1483-92 | RHAPSIDO | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 0078-1483-92 | RHAPSIDO | 2 in 1 CARTON | TABLET | 2 | | 2 |
| 0078-1483-93 | RHAPSIDO | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0078-1483-20 | 00078148320 | 60 TABLET in 1 BOTTLE (0078-1483-20) | 60 tablet | 2025-09-30 | No | No | Historical |
| 0078-1483-92 | 00078148392 | 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE | 2 bottle | 2025-09-30 | Yes | No | Historical |
| 0078-1483-93 | 00078148393 | 30 TABLET in 1 BOTTLE (0078-1483-93) | 30 tablet | 2026-03-23 | Yes | No | Historical |